Clinical Research Regulatory Coordinator

1 month ago


Lafayette, United States Sunwise Clinical Research, LLC Full time

Job Description:

We are seeking a detail-oriented and highly organized Clinical Research Regulatory Coordinator to join our research team. This role is responsible for overseeing the regulatory aspects of clinical trials, ensuring compliance with all regulatory requirements, and maintaining essential study documentation. The ideal candidate will play a critical role in supporting the research team, ensuring the ethical conduct of studies, and safeguarding patient rights and safety.

Key Responsibilities:

  • Regulatory Document Preparation: Prepare, submit, and maintain regulatory documents, including IRB submissions, amendments, safety reports, and renewals for all clinical trials.
  • Compliance Monitoring: Ensure that all studies adhere to local, state, and federal regulations, as well as institutional policies and Good Clinical Practice (GCP) guidelines.
  • Protocol Review and Approval: Manage the submission and tracking of study protocols, amendments, and consents through regulatory and ethics committees.
  • Study Start-Up and Close-Out: Coordinate regulatory requirements during study start-up, maintenance, and close-out phases, ensuring all documentation is current and complete.
  • Informed Consent Documentation: Review and verify informed consent forms to ensure compliance with regulatory and protocol-specific requirements.
  • Audit and Inspection Preparation: Support preparation for audits and inspections by regulatory authorities and sponsors, ensuring all regulatory documents and records are inspection-ready.
  • Education and Training: Train study team members on regulatory requirements and compliance policies; serve as a resource for regulatory questions and issues.
  • Record Maintenance: Maintain up-to-date regulatory binders and study files, ensuring documentation accuracy, accessibility, and compliance with retention policies.
  • Reporting and Communication: Facilitate communication between the study team, investigators, sponsors, and regulatory bodies; report protocol deviations, adverse events, and safety information as required.

Qualifications:

  • Education: Bachelor’s degree in a health science field; certification in clinical research (e.g., SOCRA, ACRP) preferred.
  • Experience: Minimum of 2-3 years of experience in clinical research with a focus on regulatory compliance.
  • Knowledge: Strong knowledge of clinical research regulatory requirements, including FDA regulations, GCP guidelines, and IRB processes.
  • Skills: Exceptional organizational skills, attention to detail, and proficiency in regulatory documentation software and clinical trial management systems.
  • Communication: Strong written and verbal communication skills, with the ability to manage multiple tasks and meet regulatory deadlines.

What We Offer:

  • Competitive Salary commensurate with experience
  • Comprehensive Benefits Package including health, dental, and retirement options
  • Professional Development Opportunities for continuing education and certification
  • Supportive Team Environment dedicated to ethical and impactful research

If you are passionate about regulatory compliance and clinical research, we invite you to apply for this essential role.



  • Lafayette, California, United States Sunwise Clinical Research, LLC Full time

    Job SummaryWe are seeking a detail-oriented and highly organized Clinical Research Regulatory Coordinator to join our research team at Sunwise Clinical Research, LLC.


  • Lafayette, United States Sunwise Clinical Research, LLC Full time

    Job Description:We are seeking an experienced and detail-oriented Senior Study Coordinator to join our clinical research team. This role will lead the coordination and management of complex clinical trials, ensuring compliance with regulatory standards and efficient trial operations. The Senior Study Coordinator will work closely with investigators, research...


  • Lafayette, United States Velocity Clinical Research, Inc. Full time

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are...


  • Lafayette, United States Velocity Clinical Research, Inc. Full time

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are...


  • Lafayette, California, United States Sunwise Clinical Research, LLC Full time

    About the Job: As a Senior Study Coordinator, you will be responsible for leading the coordination and management of complex clinical trials. You will work closely with investigators, research staff, and external partners to support high-quality, timely, and reliable data collection.Key Skills and Qualifications:Education: Bachelor's degree in a healthcare...


  • Lafayette, United States Medtronic Full time

    Careers that Change Lives The Sr. Clinical Research Director, Robotic Surgical Technologies and Digital Technologies (RST + DT) reports to the VP, Clinical Research Surgical. This position is responsible for directing all global clinical research activities and programs to generate clinical evidence in support of the business. The Clinical Research...


  • Lafayette, Louisiana, United States Lifelancer Full time

    About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Job DescriptionThis role oversees the coordination of regulatory submissions, leads material compilation for submissions, license renewals, and annual registrations. It also involves developing...


  • Lafayette, Colorado, United States Lifelancer Full time

    About the RoleLifelancer is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. As a Regulatory Affairs Expert, you will play a pivotal role in shaping the company's regulatory strategies for new and existing products.Responsibilities:Directs or performs coordination and preparation of document...


  • Lafayette, Louisiana, United States Lifelancer Full time

    Job OverviewWe are seeking an experienced Regulatory Affairs Manager to join our team at Lifelancer. The ideal candidate will have a strong background in regulatory affairs, with a minimum of 7 years of experience and 5+ years of managerial experience.This role is responsible for leading the development and implementation of global regulatory strategies for...


  • Lafayette, United States Alameda Health System Full time

    Summary Alameda Health System offers outstanding benefits that include: 100% employer health plan for employees and their eligible dependents Unique benefit offerings that are partially or 100% employer paid Rich and varied retirement plans and the ability to participate in multiple plans. Generous paid time off plans This position may be eligible...


  • Lafayette, Colorado, United States Intermountain Health Full time

    About the RoleAs a Clinical Coordinator at Intermountain Health, you will play a vital role in improving the health of patients with chronic conditions or complex needs. Working collaboratively with physicians and other healthcare professionals, you will educate patients and families to help them manage their healthcare needs.Your Key...


  • Lafayette, United States Indiana University Health Full time

    Are you ready to elevate your nursing career with Indiana's #1 Healthcare system? Join our dedicated team at IU Health, where we strive to deliver exceptional patient care and foster a culture of clinical excellence. As a leading healthcare provider, we are committed to continuous improvement, professional development, and ensuring the highest standards of...


  • Lafayette, Louisiana, United States Lifepoint Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Assessment Coordinator to join our team at Sycamore Springs, part of Lifepoint Behavioral Health. As a key member of our clinical team, you will be responsible for assessing patients who present for treatment and providing quality care to those in need.


  • Lafayette, Indiana, United States Lifepoint Health Full time

    About the RoleWe are seeking a highly skilled Clinical Mental Health Care Coordinator to join our team at Sycamore Springs, part of Lifepoint Behavioral Health. As a Clinical Mental Health Care Coordinator, you will play a crucial role in providing compassionate care to patients seeking treatment for substance abuse, dual diagnosis, or psychiatric disorders.


  • Lafayette, Colorado, United States Intermountain Health Full time

    Job SummaryThis role requires a clinical expert with a focus on collaborative support for clinical excellence. The ideal candidate will have experience in integrating best and evidence-based nursing practice within a specialty or practice area.The Nursing Professional Development Specialist designs, implements, and evaluates patient-specific and...


  • Lafayette, Indiana, United States Lafayette, IN Full time

    Job SummaryWe are seeking an experienced Director of Clinical Operations to join our team at Trilogy Health Services in Lafayette, IN. As a key member of our nursing leadership team, you will be responsible for assisting the Director of Health Services in overseeing the day-to-day functions of the Nursing Service Department.About the RoleThe successful...


  • Lafayette, Louisiana, United States Our Lady of the Lake Regional Medical Center Full time

    We are seeking a skilled Licensed Practical Nurse to join our Adult Urology Clinic team at Our Lady of the Lake Regional Medical Center. This is a full-time opportunity with a competitive salary range of $62,000 - $72,000 per year and a 1-year commitment. As an LPN, you will play a vital role in providing patient care and assisting our healthcare team with...


  • Lafayette, Louisiana, United States Our Lady of the Lake Regional Medical Center Full time

    Job SummaryThe LPN Clinic is responsible for providing patient care following established standards and practices. This role assists physician, nurse, and staff with the daily coordination of patient care and patient access.Duties and ResponsibilitiesCoordinates patient flow, schedules appointments, procedures, tests, and referrals.May serve as a preceptor...


  • Lafayette, California, United States California Department of Education Full time

    Job OverviewWe are seeking a skilled Licensed Vocational Nurse to join our team in Lafayette, California. As a Clinical Care Coordinator - LVN, you will play a vital role in delivering high-quality patient care and ensuring the well-being of our students.About the EmployerThe Lafayette School District is a renowned TK-8 school district, proudly serving 3,220...


  • Lafayette, Indiana, United States TotalMed Full time

    TotalMed is Seeking a Registered Nurse-Step Down UnitOur team of dedicated healthcare professionals is committed to delivering exceptional patient care, and we are currently looking for a qualified Registered Nurse-Step Down Unit to join our ranks. This is an excellent opportunity for individuals who are passionate about providing high-quality patient care...